NL-OMON21196Not yet recruitingNot Applicable
Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy
The Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam, The NetherlandsSt. Antonius Hospital, Nieuwegein, The Netherlands0 sites30 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
/A
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection, and not a resection of the oesophagus and cardia)
- •T3-T4 tumour based upon CT-scan and/or EUS results
Exclusion Criteria
- •Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
- •Signs of local irresectability
Investigators
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A study designed to compare the effect of two treatment types in gastric cancer patients with peritoneal metastasis, standard systemic chemotherapy vs surgery combined with hyperthermic chemotherapy in the abdominal cavity.Gastric cancer with peritoneal carcinomatosis or tumour positive cytologyMedDRA version: 20.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856MedDRA version: 21.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10057647Term: Cytoreductive surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10067093Term: Intraperitoneal hyperthermic chemotherapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10061965Term: GastrectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005695-15-NLKI-AV226